Volume : 09, Issue : 06, June – 2022

Title:

39.A REVIEW: METHOD DEVELOPMENT AND VALIDATION OF AMLODIPINE AND VALSARTAN.

Authors :

Mr. Mahesh Shinde, Dr. Ashok Pingale, Mr. Ganesh Dhikale, Ms. Vidhyatai Jondhale, Mr. Amol Rathod, Ms. Shravasti Wathore

Abstract :

The key role of the amlodipine drug is, it is the calcium channel blocker. Amlodipine is the drug molecule used to treat the high blood pressure; also, this medication is used for the coronary artery disease. In 1990 amlodipine was approved for its medical use and it was patented in 1982. In comparison with the other class of medications used to lower the blood pressure, amlodipine as a calcium channel blocker is having the greater protection against the stroke. With the variety of the other medication, amlodipine can be used as the combination for treatment. Valsartan is one of the combinations that can be taken along with amlodipine to treat the hypertension where, valsartan is the angiotensin II receptor blocker. Along with the high pressure and heart failure, valsartan is the medication that can be used to treat diabetic kidney disease. For analyzing this combination qualitatively and quantitatively, analytical techniques were found to be effective. Various research articles, literature papers were collected and reviewed reporting the analytical techniques mostly by HPLC and spectrophotometric for amlodipine and losartan and their combination. Review articles will find to be advantageous for developing an accurate and precise analytical method and for their validation studies.
Keywords: QBD approach, Amlodipine, Valsartan, RP-HPLC, method development and validation.

Cite This Article:

Please cite this article in press Mahesh Shinde et al, A Review: Method Development And Validation Of Amlodipine And Valsartan., Indo Am. J. P. Sci, 2022; 09(6).,

Number of Downloads : 10

References:

1. “Amlodipine Besylate”. Drugs.com. American Society of Hospital Pharmacists. Archived from the original on 4 June 2016. Retrieved 22 July 2016.
2. ^ The ESC Textbook of Preventive Cardiology: Clinical Practice. Oxford University Press. 2015. p. 261. ISBN 9780199656653.
3. Fischer, Jnos; Ganellin, C. Robin (2006). Analogue-based Drug Discovery. John Wiley & Sons. p. 465. ISBN 9783527607495.
4. ^ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
5. Ananchenko, Gennady; Novakovic, Jasmina; Lewis, Johnathan (1 January 2012). “Chapter 2 – Amlodipine Besylate”. Profiles of Drug Substances, Excipients and Related Methodology. Academic Press. 37: 31–77. doi:10.1016/b978-0-12-397220-0.00002-7. ISBN 9780123972200. PMID 22469316.
6. ^ Jump up to:a b “Amlodipine”. www.drugbank.ca. Retrieved 30 January 2019.
7. ^ Clusin, William T.; Anderson, Mark E. (1 January 1999). Calcium Channel Blockers: Current Controversies and Basic Mechanisms of Action. Advances in Pharmacology. Vol. 46. Academic Press. pp. 253–296. doi:10.1016/s10543589(08)60473-1. ISBN 9780120329472. PMID 10332505.
8. ^ Jump up to:a b c Nazzaro, P; Manzari, M; Merlo, M; Triggiani, R; Scarano, AM; Lasciarrea, A; Pirrelli, A (1995), “Antihypertensive treatment with verapamil and amlodipine. Their effect on the functional autonomic and cardiovascular stress responses.”, European Heart Journal, 16 (9): 1277–84, doi:10.1093/oxfordjournals.eurheartj.a061086, ISSN 0195668X, PMID 8582392
9. “Norvasc- amlodipine besylate tablet”. DailyMed. 14 March 2019. Retrieved 29 December 2019
10. Beresford, A. P.; McGibney, D.; Humphrey, M. J.; Macrae, P. V.; Stopher, D. A. (1 January 1988). “Metabolism and kinetics of amlodipine in man”. Xenobiotica. 18 (2): 245–254. doi:10.3109/00498258809041660. ISSN 00498254. PMID 2967593.
11. ^ Nayler, Winifred G. (2012). Amlodipine. Springer Science & Business Media. p. 105. ISBN 9783642782237. Archived from the original on 8 September 2017.
12. ^ Brittain, Harry G. (2012). Profiles of Drug Substances, Excipients and Related Methodology. Academic Press. ISBN 9780123977564. Archived from the original on 8 September 2017.
13. ^ Murdoch, David; Heel, Rennie C. (March 1991). “Amlodipine”. Drugs. 41 (3): 478–505. doi:10.2165/00003495199141030-00009. PMID 1711448
14. “Valsartan Monograph for Professionals”. Drugs.com. American Society of Health-System Pharmacists. Retrieved 3 March 2019.
15. “Sacubitril and Valsartan Monograph for Professionals”. Drugs.com. 7 November 2019. Retrieved 12 February 2020.
16. “Valsartan Pregnancy and Breastfeeding Warnings”. Drugs.com. Retrieved 3 March 2019.
17. Fischer J, Ganellin CR (2006). Analogue-based Drug Discovery. John Wiley & Sons. p. 470. ISBN 9783527607495.
18. British national formulary : BNF 76 (76 ed.). Pharmaceutical Press. 2018. p. 179. ISBN 9780857113382.
19. “The Top 300 of 2019”. ClinCalc. Retrieved 16 October 2021.
20. “Valsartan – Drug Usage Statistics”. ClinCalc. Retrieved 16 October 2021
21. ^ Fischer, Jnos; Ganellin, C. Robin (2006). Analogue-based Drug Discovery. John Wiley & Sons. p. 470. ISBN 9783527607495.
22. ^ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
23. ^ British national formulary : BNF 69 (69 ed.). British Medical Association. 2015. p. 127. ISBN 9780857111562.
24. ^ Jump up to:a b “The Top 300 of 2019”. ClinCalc. Retrieved 16 October 2021.
25. https://ijpsr.com/bft-article/new-validated-stability-indicating-rp-hplc-method-for-simultaneous-estimation-ofamlodipine-besylate-and-valsartan-in-pharmaceutical-formulation/
26. https://www.hindawi.com/journals/jamc/2012/108281/
27. https://www.jgtps.com/admin/uploads/wfYOdA.pdf
28. https://www.researchgate.net/publication/265267933_RP-HPLC_method_development_and_validation_for_simultaneous_estimation_of_Losartan_Potassium_Amlodipine_Besilat e_and_Hydrochlorthiazide_in_tablet_dosage_form
29. https://www.researchgate.net/publication/266039801_Stability_Indicating_RP-HPLC_Method_for_Simultaneous_Estimation_of_Valsartan_and_Amlodipine_in_Capsule_Formulation
30. https://www.researchgate.net/publication/283777661_QbD_based_method_development_forsimultaneous_quantification _for_Amlodipine_besilate_Hydrochlorothiazide_and_olmesartan_medoxomil_filmcoated_tablet_dissolutions_in_differen t_dissolution_media_by_RP-HPL
31. https://ajpaonline.com/AbstractView.aspx?PID=2014-4-3-3
32. https://www.ijpsonline.com/articles/spectrophotometric-and-hplc-methods-for-simultaneous-estimation-of-amlodipinebesilate-losartan-potassium-and-hydrochlorothiazide-.html
33. https://ajpaonline.com/AbstractView.aspx?PID=2020-10-2-8